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Ranbaxy pleads guilty to adulteration charges

In a blow to India’s growing reputation as the “pharmacy of
the world”, the US Department of Justice has imposed fines
in civil and criminal cases, up to a total of $500 million, on
Ranbaxy USA Inc, a subsidiary of the Indian pharma major,
Ranbaxy Laboratories. The company pleaded guilty to charges
of adulteration of drugs produced at its plants in Paonta Sahib
and Dewas in India. The Department of Justice has stated that
the company admitted that inspections of the Dewas facility
by the US Food and Drug Administration (FDA) in 2006 and
2008 found evidence of incomplete testing records, and an
inadequate stability programme and manufacturing practices,
in breach of regulations. The company also pleaded guilty to
making fraudulent statements to the FDA about how it tested
drugs at two of its Indian plants.

Meanwhile, Daiichi Sankhyo, which purchased the company
from the Singh family, has also filed a complaint against the
former owners for non-disclosure of the details of the US
investigation before its purchase of the company. To those
concerned with access to affordable healthcare for all, this
seems a prophecy foretold. If a big drug manufacturer like
Ranbaxy can be so negligent in the US market, known for its
stringent quality control, one can only imagine the quality
of the generic drugs in the Indian market. Also, the silence of
the Indian health authorities on the subject is deafening. It is
reported that the government has asked the Drugs Controller
General’s office to re-examine the documents based on which
approvals have so far been granted to the company.

Central scheme for free generic medicines shelved

The much-hyped plan to supply free generic medicines at
government health centres and hospitals for one year has been
shelved by the health ministry. The scheme, with a planned
budget of Rs 6000 crore per year, has been discarded due
to financial constraints and the failure to put in place a drug
procurement policy over the past 18 months. The states have
now been asked to formulate their own schemes for the supply
of free drugs and seek funds under the National Rural Health
Mission.

The move to make it mandatory for doctors to prescribe drugs
by their generic rather than brand names also seems to have
fizzled out. The only step taken in that direction so far has been a circular issued by the Medical Council of India to government medical colleges and hospitals earlier this year, but it had little effect.

The plan to provide free generic drugs was recommended in
the report of the high-level expert group (HLEG) appointed in
2011 to look into the Universal Health Coverage plan. The HLEG
had found that medicines accounted for 76% of out-of-pocket
expenditure on health.

A government official said, “We have neither the kind of
resources that a nationwide free drugs scheme requires, nor
the infrastructure to ensure glitch-free procurement and
distribution of drugs. Attempting something so ambitious
without the infrastructure would amount to courting trouble,
and even possible litigations. At this moment we can only
support states if they formulate their schemes and come to
us with adequate facilities for warehousing and an IT-enabled
supply chain. Many states have started giving free drugs too.”

Free medicine scheme in Rajasthan sees more girls
getting treatment

A study of the scheme for free medicines being implemented
in Rajasthan has revealed that there has been a twofold to
threefold increase in the treatment of girl children (0-6 years
of age) in the six months since October 2012, when the scheme
became operational. The highest increase has been in Jhalawar
district, where there has been a threefold rise in the number of
girl children in this age group being brought for treatment. In
Barmer district, the increase has been 90%-100%. The report
says, “In simple terms, now that the medicines are ‘free’, people
are finally flocking to hospitals to avail treatment for their girl children, implying they were not being treated whenever it
implied a financial cost.”

Dr Hemant Acharya from the organisation, Save the Child, said,
“With the government initiative of free medicine, free medical
tests, and schemes like the Shubh Laxmi Yojna, people are now
willing to bring their girl child for medical attention, which will be a boon to save the female child.” Around 10 crore people
in the state are reported to have benefited from the scheme in
the seven months since its inception.

Women health activists hounded

A five-year-old case has been revived against Madhuri
Krishnaswami, a health activist working with tribal communities
in the district of Barwani, Madhya Pradesh. The court ordered
her arrest in connection with a case registered against her
and others in 2008 for their protests against corruption in
the healthcare facilities of the state. The activist works with
the Jagrit Adivasi Dalit Sanghatan and had exposed several
instances of corruption in programmes implemented under
the Mahatma Gandhi National Rural Employment Guarantee
Act. The report mentions that the local officials tried to have
her externed from the area, but failed due to the protests of
the citizens. The judge suggested that Krishnaswami apply for
bail and when she refused to do so, sent her to jail on 14 days
judicial remand. Residents of the area have been staging sit in
protests at six police stations in the district, demanding the
immediate release of the activist.

Meanwhile, Soni Sori, an adivasi teacher and activist, has been
in jail for over 17 months. She has complained that she was
subjected to brutal sexual torture, including having stones
forced into her private parts, by the Chattisgarh police in
October 2011. Her complaints were reportedly dismissed by
the Raipur medical authorities, which claimed that she was
“malingering” or feigning illness. It was only after the Supreme
Court’s intervention that she was re-examined by doctors in
Kolkata and treated for her injuries. To add insult to injury, the
government of Chattisgarh has now announced that she will
be made to undergo a “psychiatric examination”.

Groups of women activists nationwide have protested against
this as being a malafide move to declare her of unsound mind,
thus paving the way for the dismissal of her allegations of
police brutality. They have also condemned the statement of
a member of the team of the National Commission of Women
which visited the activist that Sori was doing fine and only
needed psychological counselling. This remark is said to have
been the basis of the state government’s plan to put Sori
through a psychiatric examination.

New MCI board approved

The Medical Council of India (MCI) is to be reconstituted,
with former director general of health services, RK Srivastava, replacing Dr KK Talwar as chairman of the council’s Board of
Governors.

The medical regulator will have a seven-member board,
approved by health minister Ghulam Nabi Azad, and will serve
for a term of six months, within which elections will be held
and the MCI’s original democratic structure restored.

A bill to this effect will have to be passed in Parliament. The government has issued an ordinance for the formation of
the new MCI Board of Governors which is to run the medical
regulatory body.

The term of the last Board of Governors expired on May 13,
making it necessary for the government to issue an ordinance
for the formation of a new board to run the MCI until
Parliament passes the new Indian Medical Council Amendment
Act. The latter provides for the restoration of an elected MCI
and fixes the tenure of its president to root out corruption.

Quinvaxem vaccination suspended in Viet Nam

The use of Quinvaxem, a vaccine meant to prevent five
common, potentially fatal childhood diseases-diphtheria
(D), tetanus (T), pertussis (P, whooping cough), hepatitis
B (HepB), and haemophilus influenza type b (Hib), was
suspended by the Viet Nam ministry of health on May 4.
This followed reports of at least nine deaths of vaccinated
infants and numerous cases of serious allergic reactions
over the preceding six months. The infants had reportedly
been in good health before being vaccinated, but suffered
convulsions and died soon after vaccination. Several tests
were conducted to investigate the matter, but the vaccine
was not found to be directly linked with either the deaths
or the allergic reactions. Nor was there any evidence to
exclude the vaccine as a cause of the adverse effects. The
reports say that the cases were from different provinces,
and the batches of vaccine were of good quality and met all
the requirements.

According to a government spokesperson, 20 out of 42 batches
of the vaccine were followed by minor to severe allergic
reactions. The spokesman said whole-cell pertussis vaccines,
like Quinvaxem, were among those that gave rise to the
maximum number of allergic reactions. Now that a decision
has been taken to stop using Quinvaxem, the government has
to decide on which substitutes can be used to avoid a gap in
the immunisation of infants.

Patients’ right to refuse information

The American College of Medical Genetics and Genomics
(ACMG) recently recommended that during genetic
sequencing for any medical reason, 57 other specific genes
must also be examined for incidental findings, and both the
doctor concerned and the patient must be informed of the
results. Further, the ACMG clarified that failure to report the
information would be considered unethical. The only way a
patient can avoid having 57 genes tested is by refusing the
gene sequencing altogether.

This step has led to a huge controversy, with Megan Alysse
and Marsha Michie of the Stanford University of Biomedical
Ethics arguing that while patients have the right to be given
information on their health, no one has the right to force
information on them if they do not wish to receive it. The
ACMG’s recommendation has also been attacked on the
ground that such testing is very expensive.

“No one should be able to interfere with your ability to accept
or decline access. We think that’s where these recommendations
are problematic, because they do suggest that your physician
should interfere in that decision by essentially saying, ‘You have
to accept this information.’ And there is certainly evidence that
some people do not want information about long-term health
risks, especially in children,” say the two researchers.

Spinning money from new technologies

A comment in the Economic and Political Weekly advises a
cautious approach to the media hype about the double
mastectomy which the Hollywood actress, Angelina Jolie, opted for, apparently as a precaution against the threat posed
by a genetic predisposition to breast cancer. Media reports
have been applauding this step as a brave one and one which
will encourage other women to deal with the threat of breast
cancer. The writer expresses “an instinctive mistrust of the
manner in which modern technology in the last few decades
has invaded and displaced all other forms of medical care,
creating simultaneously a kind of pseudo-scientific common
sense”.

Applying this to the Jolie case, she says “the liberal references
to percentages”, as in the percentage risk of cancer, “without
ever clarifying sample sizes, racial or national contexts, or age
profiles, is a classic instance of the misuse of statistics. Most
reports mention hitherto unheard of genes (except presumably
in medical circles) and within a mere 48 hours or so the BRCA
gene has achieved a resounding degree of notoriety. The
combination of math and science in this fashion, needless
to say, is a noxious cocktail. And as a marketing strategy, not
entirely unfamiliar.” The writer expresses her increasing mistrust of a medical industry that rakes in huge profits by creating anxiety about the possibility of potential health risks. This is discussed in the context of the proliferation of two proven “money spinners”: preventive hysterectomies and assisted
reproductive technologies.

The comment asserts that while women in particular must be
encouraged to take charge of their own bodies, this “cannot
happen in the absence of a demand for greater accountability
and transparency from the medical scientific empire, whose
solutions are invariably industry-driven.” It also stresses the
need to press governments and the medical establishment
to invest in projects aimed at understanding the relationship
between food, lifestyle, environment and changing global
health trends, and to conduct research in this area.